The Effect of IV Dexamethasone on the Duration of Analgesia of Spinal Anaesthesia for C-Sections at a Jamaican Hospital

November 9, 2020 updated by: Renee Nesbeth, The University of The West Indies

Randomised Controlled Trial Comparing the Effect of Intravenous Dexamethasone vs. Placebo on the Duration of Analgesia of Spinal Anaesthesia for Caesarean Sections at the Victoria Jubilee Hospital in Jamaica

Dexamethasone is one of many adjuncts tested to prolong the duration of spinal anesthesia and its analgesic effect. The intent of this, a single-site, double-blinded, randomized controlled trial, is to determine if a single intravenous (IV) 8 mg dose of Dexamethasone given after clamping of the umbilical cord at Caesarean section will prolong the duration of analgesia provided by spinal anesthesia when compared to placebo. This has the power to determine if the findings in previous studies hold true in the population of women who undergo C-sections at the Victoria Jubilee Hospital. This method does not require expert skill and equipment, as such, it can be easily implemented, with no major adverse effects in the population described and provide an effective option for multimodal analgesia.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This study is being conducted in accordance with the Good Clinical Practice guidelines as enunciated in the international Conference on Harmonization (ICP/GCP) of 2016 and the Declaration of Helsinki, 2013.

Sample Size:

The sample size calculated based on a study done by Shahraki et al who studied the efficacy of intravenous Dexamethasone in prolonging the duration of Spinal Anesthesia in elective Caesarean Section in an Indian population (36).

The following values were used for the calculation of the sample size: the required value of α was 5%, β was 10%, a clinically significant difference in Visual Analogue Scale (VAS) score at 1-hour post-surgery was considered 2 and the expected standard deviation was 2.5 (36). The equation used was:

n = (Zα/2+Zβ)2 *2*σ2 / d2,

where Zα/2 is the critical value of the normal distribution at α/2 (α is 0.05), Zβ is the critical value of the normal distribution at β of 0.10. σ2 is the population variance (2.52), and d is the difference to be detected (2). The calculated sample size is 14 patients in each group. In order allow for a potential loss of data up to 10% the target sample size required would be 16 in each group.

Assumptions:

  1. The population size is limited by:

    1. patient's age,
    2. gestational age,
    3. the type of birth - only Caesarian births,
    4. use of a single hospital - VJH
    5. the duration of the research of approximately 2 to 3 months.
  2. As a result of item 1, when the Finite Population model is used to determine the sample size -

S = Z2 * p(p-1) / E2

1 + (Z2 * p(p-1) / E2N)

Other parameters include:

  1. 95% Confidence level
  2. Margin of error 5%
  3. Number of live births at VJH in 2016 estimated at 8140 live births
  4. Number of Caesarian births same period = 1652
  5. Percent of Caesarian births (with access to in 2 to 3 months) = 3.6 to 5%

The computed sample size ranges from 53 (2 months) to 72 (3 months) The decision was made to include 30 patients in each group totaling 60 persons for the sample size for this study.

Research assistants received training in the study protocol. Presentations were made to the registration clerks, obstetricians, midwives and other nursing staff to introduce them to the study.

Recruitment The registration clerk informs the patients of the study being carried out from admission to hospital. The ward nurse, upon admitting the patient, determine if they meet the criteria and indicates same to a member of the research team. Written informed consent is obtained by an independent research assistant, once it is confirmed that the patient meets the criteria, to avoid any perception of coercion on the night before or the morning of their procedure. The patient's autonomy is respected and quality medical care will is provided for those who participate in the study as well as those who decline.

Conceptual Definition of Variables Duration of analgesia: the time from intrathecal injection to the time of the first request for analgesia or Visual Analogue Pain Scale score > 4.

Duration of motor blockade: the time from intrathecal injection to the time when the patient is able to flex their knees with free movement of their feet in any plane.

Data Collection/ Storage The data collected for research is stored in a secured area in the Anesthetic Office at the Kingston Public Hospital with access limited to the research team only. Back-up of the data is stored off-site in a locked room in the Anesthetic Office of the University Hospital of the West Indies. Each patient is assigned a study number, and strict security measures are employed to ensure maximum protection of data and the privacy of the research subjects such as password protection and anonymity of data.

If a participant decides to withdraw from the study, the data collected prior to withdrawal may be used in data analysis and the same anonymity applies. Withdrawal from the study will not affect the participant's access to quality health care.

Source Data Verification This is done by cross-referencing the data entered on the data collection forms with the patients' dockets.

Statistical Analysis The data will be managed and analyzed using Statistical Package for the Social Sciences [SPSS] version 26.0 (2019). Uni-variate, bi-variate and multi-variate analysis of the data will be done. Uni-variate analysis will include means ± standard deviation. Bi-variate analysis will include will include independent/ paired t-tests for quantitative data; Chi square test and Mann-Whitney's U test where applicable. Multi-variate analysis will include regression and other measurements where necessary. A p value of less than 0.05 will be deemed statistically significant.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Jamaica
    • Non-US/Canada
      • Kingston, Non-US/Canada, Jamaica, 6
        • Recruiting
        • Victoria Jubilee Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 43 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients at Victoria Jubilee Hospital in Jamaica, scheduled for non-emergent LSCS under spinal anesthesia
  • Age: 18 to 45 years
  • Gestational Age: 37 weeks or more
  • American Society of Anesthesiologists physical status class II
  • Singleton fetus

Exclusion Criteria:

  • Emergent Indication for caesarean section including, but not limited to:
  • Fetal distress
  • Cord prolapse
  • Eclampsia
  • Severe pre-eclampsia
  • Placental abruption
  • Placenta praevia
  • Multiple Gestation
  • Allergy to glucocorticoids/opioids/Diclofenac Na/ local anesthetics
  • Contra-indication to Spinal Anesthesia
  • Gestational Diabetes or Pre-gestational Diabetes
  • Asthma
  • Other uncontrolled comorbidities (such as cardiac, respiratory, renal, inflammatory, endocrine disease)
  • Chronic steroid use
  • history of Peptic Ulcer Disease or Glaucoma
  • history of chronic pain
  • Illicit drug users (including marijuana)
  • Any patient who requires general anesthesia secondary to failure of spinal anesthesia will also be excluded

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study Drug A
Dexamethasone 8mg intravenous administration stat dose post clamping of the umbilical cord
Drug: Dexamethasone
Intravenous of Dexamethasone 8 mg post clamping of the umbilical cord
Other Names:
  • Study Drug A
Placebo Comparator: Study Drug B
Normal saline 2cc intravenous stat dose administered after clamping of the umbilical cord
Other: Placebo
2cc 0.9% Saline
Other Names:
  • Study Drug B

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of analgesia
Time Frame: first 4 hours after spinal anesthesia administered
The duration of time from the administration of drugs intrathecally for spinal anesthesia to the first request for analgesia or first time the pain score is greater than 4
first 4 hours after spinal anesthesia administered

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of The West Indies

Collaborators

National Health Fund of Jamaica

Investigators

  • Principal Investigator: Christine Stephen, MB;BS, DM, University of the West Indies

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 27, 2020

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

November 9, 2020

First Submitted That Met QC Criteria

November 9, 2020

First Posted (Actual)

November 10, 2020

Study Record Updates

Last Update Posted (Actual)

November 10, 2020

Last Update Submitted That Met QC Criteria

November 9, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VJH Dexa Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Sharing Time Frame

January 2021 - December 2028

IPD Sharing Supporting Information Type

  • Study Protocol
  • Informed Consent Form (ICF)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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